Purpose: Regulates possession, use, and transfer of biological select agents and toxins (BSATs) that pose severe threats to public, animal, or plant health.
Key Agencies: Jointly managed by CDC/HHS and APHIS/USDA.
Current Approach: List-based taxonomy regulation of BSATs.
Identified Gaps in FSAP
1. Agent Identification: Difficulty identifying and regulating novel/ engineered pathogens with functional similarity to select agents.
2. Response Speed: Lengthy amendment processes for new threats may delay effective regulation.
✦ Establish a gray/in-between list system for temporary classification.
✦ Expand regulation to include all nucleic acid sequences of select agents
✦ Implement a 'near-miss' incident reporting program to improve transparency and preparedness.
✦ Automatic designation for concerning emerging pathogens.
✦ Penalize theft/possession of select agents and restrict release of functional data
Challenges/Obstacles:
• May discourage research due to increased regulatory burdens.<br>• Delays in designation may impede identification of artificial intelligence- synthesized agents.<br>• May drive select agent work abroad to less-restrictive countries.<br>• Pose difficulty in functional assessment for novel agents.
